A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma

NCT06368167 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR2554-202
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) assessed by independent review committee (IRC)

  percentage of patients who achieve completes response(CR) or partial response(PR) in the study

  around 1 year

Secondary Outcomes (5)

• ORR assessed by investigator

  around 1 year

• Progression free survival

  around 1 year

• Time to Response

  around 4 months

• Duration of response

  around 1 year

• Overall survival

  around 5 years

Study Arms (1)

SHR2554

EXPERIMENTAL

Drug: SHR2554

Interventions

SHR2554 DRUG

SHR2554

SHR2554

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥18 years
• Histologically confirmed follicular lymphoma
• Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2
• Life expectancy ≥ 12 weeks
• Treated with CD20 antibody, refractory to or relapse from prior anti-cancer therapies
• Have measurable lesions
• The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures

You may not qualify if:

• Have been treated with a compound of the same machanism;
• Accompanied by central nervous system infiltration;
• Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation or CAR-T therapy within 90 days;
• Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug
• Known active infection
• History of clinically severe cardiovascular diseases
• Have other malignancies within 5 years prior to screening Pregnant or lactating women
• The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of gastrectomy or gastric banding that affects drug absorption.
• The subject is taking a known medium or strong CYP inducer.
• Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Zhenyu Xiao

CONTACT

0518-82342973; zhenyu.xiao.zx7@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (1)